With the Registration History Report, you can generate a view of registration-related audit trail data to support regulatory requirements. You can use this report to view a history of all registration changes globally or generate Pharmacovigilance Master File (PSMF) registration history appendices.
Registration History Reports are available for a group of registrations across a specific date range or for a single registration’s entire history. When you generate the report, Vault gathers information from the audit trail across Registration records and related registered details in a Microsoft Excel file. If the registration and registered details were updated through the Manage Registered Details wizard, the Excel file also includes details about the related Regulatory Objective records.
Note: This feature is only available on RIM Registrations Vaults.
Generating the Registration History Report
To generate the Registration History Report over a specific date range:
- Navigate to the Reports tab and create a new report with the Registration object as the primary reporting object or open an existing one.
- From the report’s Actions menu, select Registration History Report. This action may have a different label in your Vault. You won’t see this option if the report doesn’t contain any records.
- In the dialog, select the Registration History date range for your report. Your report’s date range must be 120 days or less.
- Click Get History.
- Vault generates the report asynchronously and sends you a notification with a link to download the Excel file when complete.
Generating a Report for a Single Registration
You can also generate a history report for a single registration. Vault includes the entire history for that registration in the report. To generate a history report for a single registration:
- Navigate to a Registration record.
- From the Actions menu, select Registration History Report.
- Vault generates the report asynchronously and sends you a notification with a link to download the Excel file when complete.
About the Registration History Report Excel File
The Registration History Report Excel file includes two sheets:
- The Cover Page sheet includes the date the report was generated, the requesting user, the source Vault, and the date range.
- The Registration History Report sheet includes fields from the audit trail and fields for each record, grouped by object. The fields included in each object group depend on your Admin’s configuration. If there is no related data, Vault does not include this sheet.
Related Permissions
Your security profile must include the permissions below to generate the Registration History Report. Vault only includes the Registration records and fields you can see in the generated Excel file.
| Type | Permission | Controls |
|---|---|---|
| Security Profile | Application: RIM Registrations: Bulk Registration History Report | Ability to generate the Registration History Report over a specific date range. |
| Security Profile | Object: Registration: Read | Ability to view Registration records in the report. |
| Security Profile | Object: Regulatory Objective: Read | Ability to view Regulatory Objective records in the report. |